Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
LIPOFEN vs TRILIPIX
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Lipofen (fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It activates PPARα, which increases lipolysis and elimination of triglyceride-rich particles from plasma by stimulating lipoprotein lipase activity and reducing apolipoprotein C-III production. This leads to decreased triglyceride levels and increased HDL cholesterol.
TRILIPIX (fenofibric acid) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, and reduces production of apoprotein C-III.
Adjunct to diet for treatment of hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia),Adjunct to diet for treatment of primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb) when statins are contraindicated or not tolerated
Adjunctive therapy to diet for severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia),Primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb)
For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.
135 mg orally once daily, not to exceed 135 mg/day.
5-7 hours (prolonged in renal impairment; may exceed 24 hours in severe CKD).
Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 10-35 hours), allowing once-daily dosing.
Primarily metabolized by glucuronidation via UDP-glucuronosyltransferases (UGT1A1, UGT1A3, UGT2B7) to fenofibric acid, the active metabolite. Minor CYP450 involvement (CYP3A4, CYP2C8, CYP2C19). Renal elimination of conjugates and unchanged drug.
Fenofibric acid is primarily metabolized via glucuronidation. It is not metabolized by cytochrome P450 (CYP) enzymes.
Primarily renal (90% as unchanged drug), with <5% fecal.
Primarily renal excretion as glucuronide conjugate and unchanged drug; ~60% of dose excreted in urine as fenofibric acid and its glucuronide, ~25% in feces.
>99% bound to albumin.
Fenofibric acid is highly bound to plasma albumin (>99%).
Approximately 0.5 L/kg (low, indicating minimal tissue distribution).
Apparent volume of distribution (Vd/F) is approximately 0.9 L/kg, indicating distribution into extracellular fluid.
Oral: 30% (first-pass effect; absorption increased with food).
Absolute bioavailability of fenofibric acid from TRILIPIX is not determined; relative bioavailability compared to micronized fenofibrate is approximately 100% after oral administration.
GFR 30-59 m L/min: reduce dose by 50% (e.g., 67 mg once daily). GFR <30 m L/min: contraindicated.
Contraindicated in severe renal impairment (e GFR <30 m L/min/1.73 m²). For mild to moderate impairment (e GFR 30-59 m L/min/1.73 m²), maximum dose is 67 mg daily.
Child-Pugh Class A: no dose adjustment. Child-Pugh Class B or C: contraindicated due to risk of hepatotoxicity.
Contraindicated in Child-Pugh Class B and C hepatic impairment. No dose adjustment specified for Child-Pugh Class A; use with caution.
Not recommended in children <18 years; safety and efficacy not established.
Safety and efficacy not established in pediatric patients.
Start at lower end of dosing range; monitor renal function and adjust accordingly.
No specific dose adjustment recommended; select dose cautiously due to age-related renal function decline.
None.
There is no FDA-required black box warning for TRILIPIX.
Hepatotoxicity: Elevations of serum transaminases; monitor liver function. Discontinue if ALT > 3x ULN.,Cholelithiasis: Increases cholesterol excretion into bile, risk of gallstones.,Pancreatitis: Has been reported, especially during initiation or dose escalation.,Myopathy/Rhabdomyolysis: Risk increased when co-administered with statins.,Renal impairment: Dose adjustment required. Use with caution in patients with serum creatinine > 2.0 mg/d L.,Venothromboembolic disease: Increased risk of pulmonary embolism and deep vein thrombosis in some trials.
Risk of myopathy/rhabdomyolysis, especially in patients with renal impairment or those taking statins,Elevations in serum transaminases, possibly leading to cholelithiasis,Hepatocellular and obstructive jaundice have been reported,Monitor renal function prior to and during therapy,Not recommended in patients with severe renal impairment (e GFR <30 m L/min/1.73 m²)
Severe renal impairment (e GFR < 30 m L/min/1.73 m²),Active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities,Pre-existing gallbladder disease,Known hypersensitivity to fenofibrate or any formulation components,Nursing mothers
Severe renal impairment (e GFR <30 m L/min/1.73 m²),Active liver disease (including unexplained persistent liver function abnormalities),Pre-existing gallbladder disease,Known hypersensitivity to fenofibric acid, fenofibrate, or any component of the formulation
Take with food to enhance bioavailability. Avoid high-fat meals immediately before dosing as they may delay absorption. Grapefruit juice has no significant interaction. Alcohol should be limited or avoided due to potential for increased triglyceride levels and hepatotoxicity. No specific restriction on caffeine. Ensure adequate hydration to prevent renal complications.
Avoid high-fat meals during administration as they can alter fenofibric acid absorption. Avoid grapefruit juice as it may increase drug exposure. Alcohol consumption should be limited (no more than 1 drink per day for women, 2 for men) due to potential hepatotoxicity and worsening of hypertriglyceridemia.
LIPOFEN (fenofibrate) is classified as FDA Pregnancy Category C. Animal studies have shown embryotoxicity and teratogenicity at high doses, but no adequate human studies exist. First trimester: potential risk of congenital anomalies cannot be ruled out. Second and third trimesters: may cause fetal skeletal abnormalities and growth retardation; risk of neonatal complications if used near term. Contraindicated in pregnancy unless clearly needed.
Pregnancy category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Use only if benefit outweighs risk; may cause fetal harm due to maternal hypertriglyceridemia or drug effects.
Fenofibrate is excreted in breast milk in rats; no human data. M/P ratio unknown. Due to potential for adverse effects in nursing infants, avoid use during breastfeeding or discontinue nursing.
Not recommended. M/P ratio unknown; fenofibric acid is excreted in rat milk; potential for serious adverse reactions in nursing infants.
No specific dose adjustments are recommended due to lack of pharmacokinetic data in pregnancy. However, use is generally avoided; if deemed necessary, use lowest effective dose and monitor maternal and fetal status closely.
No established dosing adjustments; pharmacokinetics in pregnancy unknown. Use lowest effective dose if necessary; avoid in third trimester unless essential.
LIPOFEN (fenofibrate) is a PPAR-alpha agonist that reduces triglycerides and increases HDL-C. Monitor renal function before initiation and periodically; dose adjustment required if e GFR <60 m L/min/1.73m2. Avoid use in severe renal impairment (e GFR <30). May increase serum creatinine transiently. Increases risk of cholelithiasis due to cholesterol supersaturation. Concomitant statin therapy increases risk of myopathy; monitor for muscle symptoms. Use with caution in patients with hepatic impairment; contraindicated in active liver disease. May potentiate effect of oral anticoagulants; monitor INR.
TRILIPIX (fenofibric acid) is a fibric acid derivative used as an adjunct to diet for severe hypertriglyceridemia. Monitor renal function prior to initiation and periodically; dose reduction required for e GFR 30-59 m L/min/1.73m². Contraindicated in severe renal impairment (e GR <30) and active liver disease. May increase serum creatinine; typically reversible. Co-administration with statins increases risk of myopathy/rhabdomyolysis; avoid in patients with predisposing factors. Not recommended for primary prevention of coronary heart disease.
Take with meals to improve absorption. Do not break, crush, or chew capsules.,Avoid alcohol consumption as it can increase triglyceride levels and risk of liver damage.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,Notify your doctor if you develop abdominal pain, nausea, or jaundice (yellowing of skin/eyes).,Maintain a low-fat diet and exercise regularly to maximize lipid-lowering benefits.,Do not take supplements containing red yeast rice or niacin without consulting your physician.
Take TRILIPIX with or without food, but avoid taking with a high-fat meal as it may increase absorption variability.,Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.,Inform your healthcare provider if you have kidney disease, liver disease, or a history of gallbladder problems.,Do not take this medication if you are pregnant or breastfeeding without consulting your doctor.,Alcohol consumption should be minimized or avoided as it can increase triglyceride levels and liver stress.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about LIPOFEN vs TRILIPIX, answered by our medical review team.
LIPOFEN is a Fibrate Antilipemic that works by Lipofen (fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It activates PPARα, which increases lipolysis and elimination of triglyceride-rich particles from plasma by stimulating lipoprotein lipase activity and reducing apolipoprotein C-III production. This leads to decreased triglyceride levels and increased HDL cholesterol.. TRILIPIX is a Fibrate Antilipemic that works by TRILIPIX (fenofibric acid) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, and reduces production of apoprotein C-III.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between LIPOFEN and TRILIPIX depend on the specific clinical indication. These are both Fibrate Antilipemic agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of LIPOFEN is: For hypertriglyceridemia: 67-134 mg (as fenofibric acid) orally three times daily with meals. Maximum dose 200 mg/day.. The standard adult dose of TRILIPIX is: 135 mg orally once daily, not to exceed 135 mg/day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between LIPOFEN and TRILIPIX in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. LIPOFEN is classified as Category C. LIPOFEN (fenofibrate) is classified as FDA Pregnancy Category C. Animal studies have shown embryotoxicity and teratogenicity at high doses, but no adequate human studies exist. Fir. TRILIPIX is classified as Category C. Pregnancy category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Use only if benefit outweighs r. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.